Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Life Molecular Imaging SA; Piramal Imaging SA

Criteria

Inclusion Criteria:

• Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.

• Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.

• Able to give written informed consent.

• Age >/= 60 years of age

• >/= 7 years of education

Exclusion Criteria:

• Mini mental state examination (MMSE) score < 24 at baseline

• Clinical dementia rating (CDR) score > 0.5 at baseline

• Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)

• Existing or history of cancer

• History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion

• Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder

• Contraindications to MRI (Magnetic resonance imaging)

• Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression

• History of severe anaphylactic reaction or high risk of allergic reaction to drugs

• Patient has received another investigational drug in the preceding 14 days